Certain persons may engage in certain undesirable activities that have significant negative acute and/or long-term health, social, and safety implications for the person and for other associated persons. In some cases, the person may wish to quit this behavior. Often, the person's family, friends, and/or healthcare providers are also engaging with the person in an attempt to have them quit the behavior. Associated persons may also be negatively impacted by the behavior, socially, financially, and from a health perspective. Such behavioral modification or cessation attempts to terminate the undesirable behavior may be formal and administered by healthcare professionals, or the person may take their own personalized approach to cessation.
An example of such a behavioral modification program is a formal multi-modality smoking cessation program that utilizes counseling and drug therapy to achieve the end goal of abstinence from smoking. Drug therapy typically includes one or more of: nicotine replacement therapy, welbutryn, varenicline, and other drugs. Alcohol cessation programs, by comparison, may include similar approaches with counseling and drug interventions targeted specifically to achieve abstinence from alcohol use and abuse.
In a typical multi-modality smoking cessation program, participants are asked to voluntarily and honestly report on their smoking behavior before and during therapy. For example, the patient's baseline smoking behavior is measured according to the patient's own voluntary report and is based solely on their recall (i.e., patient states that they average forty cigarettes per day prior to entering program). The patient may also be asked to provide a blood sample at the clinic or hospital location to test for substances associated with smoking behavior, such as hemoglobin bound to carbon monoxide. Alternatively, the patient may be asked to exhale into a device at the clinic or hospital location to detect carbon monoxide levels in the exhaled gas from the lungs. Such tests would be performed on location and observed by the health care provider, and such tests may require processing by a professional laboratory. Based on the values of carbon monoxide or other substances at this specific point in time, a gross estimate of smoking behavior may be made by the health care professional. Limitations of such testing are that it is made at a single point in time and likely does not fully and accurately reflect the true behavior of the patient at multiple time points before entering the program. The patient may alter their behavior, for example, for days prior to testing thus making the test result less relevant and accurate.
At each visit during a patient's cessation program participation, the patient's interval smoking behavior since the previous visit is quantified by patient voluntary reporting (recollection, diary, etc.). For example, if the patient is seen weekly, they will report on their smoking behavior for the prior seven days. Typically, the patient keeps a diary or smoking log during each interval in which daily entries are made regarding the number of cigarettes smoked and certain lifestyle events that occur in conjunction with smoking behavior. This methodology relies on compliance and full disclosure by the smoker, as well as a commitment to record the data every day.
Clinical trials have shown that patients often fail to disclose their true smoking behavior when queried in this manner, grossly under-reporting the amount of smoking that takes place or forgetting certain lifestyle events that are associated with smoking. These limitations in reporting impair the effectiveness of the program. Further, blood tests or exhaled carbon monoxide breath tests may be performed on the spot at these weekly or biweekly visits, to detect substances associated with smoking. Unfortunately, such predictable and infrequent testing gives the patient the opportunity to abstain for hours or longer prior to the visit to avoid detection of smoking behavior or to lessen the positivity of the test. Such behavior results in collecting physiological data that erroneously suggests that smoking has stopped or diminished. For example, if a patient has a bi-weekly 3 pm clinic visit on Mondays, they may abstain from smoking after 9 am on the day of the visit so that their blood and exhaled breath levels of carbon monoxide decline or normalize in time for the test. Further, such spot testing by the clinic is infrequent and does not accurately represent patient behavior during non-clinic days. Due to these significant limitations, counseling and drug therapy cannot be accurately and effectively tailored to optimize patient outcomes. If healthcare professionals do not have accurate information regarding true patient behavior, for example, the efficacy of the cessation program will be severely impaired. This is one reason why failures of smoking cessation programs, as well as other behavioral cessation programs, are so high and recidivism almost guaranteed. Given the currently limited options for objectively determining a patient's smoking behavior, (or other behaviors) a more objective and accurate means of determining a patient's behavior is needed.